Strip vial and cap

ABSTRACT

Containers and methods for dispensing test strips. Embodiments of the invention include a container and a cap or an insert. The container holds or stores the test strips and the test strips may be dispensed through the cap or the insert.

CROSS-REFERENCE TO RELATED APPLICATIONS

Not applicable.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

Embodiments of the invention relate to vials for test strips. Moreparticularly, embodiments of the invention relate to storing anddispensing test strips from a vial that may be used to test analytes inbodily fluids including blood glucose levels.

2. The Relevant Technology

Diabetes is a disease that has become more manageable in recent years.Today, people with diabetes are often able to control their diabetesthrough exercise and proper diet. In addition to exercise and diet,another important aspect of diabetes management includes glucosemonitoring. In fact, glucose monitoring is often an essential part ofproper diabetes control or even diabetes prevention.

Generally, a diabetic person measures blood glucose levels several timesa day. Careful monitoring of blood glucose levels can help prevent ordelay the onset of debilitating complications such as cardiovasculardisease, blindness, kidney disease, and nerve damage.

The process of monitoring blood glucose levels includes several stepsusing appropriate equipment that includes a test strip and a bloodglucose monitor. In general, a small sample of blood is transferred toan appropriate location of the test strip. The monitor then measures theblood glucose level in the blood sample and displayed to the user.

While this process seems rather simple, there are certain steps that canprove difficult, particularly for people that are suffering from some ofthe effects of diabetes such as nerve issues and poor eyesight. Forexample, before transferring a small sample of blood to a test strip, auser is required to obtain a test strip. Test strips are often stored ina vial and a user opens the vial of test strips to extract a test strip.

However, this process can be difficult for various reasons. The size oftest strips themselves, which are often stored loosely in the vial, canmake them difficult to grasp. The size of the vial also contributes tothe difficulty of extracting a single strip. In fact, some users have totake several test strips out of the vial before they can pick up asingle test strip. As indicated previously, these problems can often becomplicated by the fact that many people with diabetes often haveproblems (e.g., poor eyesight, nerve problems) or difficulty in handlingthe test strips.

When extracting a test strip from conventional vials, the test stripsinside the vial are often subject to repeated touching, which mayadversely affect the functionality of the test strips. Also, becausesuch a user typically cannot extract a single strip without taking outseveral test strips, the user may inadvertently drop some of the teststrips onto the floor, which can lead to damaged, contaminated, orunusable test strips. In addition, test strips can be contaminated fromthe user's fingers as well. In each case, the cost of the test strips iseffectively increased for that user. In addition, the use of acontaminated test strip may lead to incorrect results and adverselyaffect the health of the user.

BRIEF SUMMARY OF THE INVENTION

These and other limitations are overcome by embodiments of theinvention, which relate to systems and methods for dispensing teststrips, including test strips used to test or monitor analytes.Embodiments of the invention may include a dispensing member that isgenerally arranged over the test strips that may be stored in containeror other storage compartment. The dispensing member can be permanentlyor semi-permanently connected with the container or other storagecompartment to form a vial. Test strips can then be dispensed from thevial through the dispensing member. By way of example only, thedispensing member can be included in various embodiments, includingvials, caps, inserts, and the like.

In one embodiment, a cap for dispensing test strips includes a bodyconfigured to detachably connect with a container. The body of the capmay include a dispensing member such as a slot through which test stripsare dispensed. The cap may also include a guiding member having a shapeto direct test strips to the slot, where they are dispensed at least oneat a time.

In another embodiment, a cap for dispensing test strips includes a bodyconfigured to connect with a container such that the test strips insideof the container are enclosed inside. The body of the cap may include adispensing member such as a diaphragm located in a recessed portion ofthe body. The diaphragm can have at least one slit formed from at leastone cross cut. The body may also include a guiding member that guides ordirects at least one of the test strips to the slit for dispensing thetest strips through the slit formed in the diaphragm. As the slit in thediaphragm expands or separates to dispense the test strips, thediaphragm exerts an inward force to hold the test strips in a dispensingposition. By holding the test strips in place, a user can easily grab asingle test strip.

In another embodiment, the dispensing member of the cap may include botha slot and a diaphragm with cross cuts. The slot may control how manytest strips are dispensed and the diaphragm may hold the test strips inplace for the user. This may prevent the dispensed test strip fromfalling out. In this example, the slot may be sized to accommodate morethan one test strip at a time. As a result, more than one test strip maybe held in a dispensing position by the diaphragm.

The cap may also include a cover that can close and open to permitaccess to the dispensing member. The cover can therefore seal or closethe dispensing member. Also, the cover may be connected to the body ofthe cap or may be separate from the cap.

These and other advantages and features of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features ofembodiments of the invention, a more particular description of theinvention will be rendered by reference to specific embodiments thereofwhich are illustrated in the appended drawings. It is appreciated thatthese drawings depict only illustrated embodiments of the invention andare therefore not to be considered limiting of its scope. The inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 illustrates a perspective view of one embodiment of a vial forstoring test strips;

FIG. 2A illustrates a cross section of the vial illustrated in FIG. 1;

FIGS. 2B-2C illustrated alternate configuration of a cap of the vialillustrated in FIG. 1;

FIG. 3 illustrates a top view of one embodiment of a cap that dispensestest strips in a controlled manner from a vial;

FIG. 4 illustrates a cross sectional view of a vial including a cap thatdispenses test strips in a controlled manner;

FIG. 5 illustrates one embodiment of a cap that is dispensing a singletest strip from a vial;

FIG. 6 illustrates a perspective view of one embodiment of a cap thatdispenses test strips in a controlled manner;

FIG. 7 illustrates an exploded cross-sectional view of the capillustrated in FIG. 6;

FIG. 8 illustrates one embodiment of a cap that is dispensing a teststrip;

FIG. 9A and 9B illustrates one embodiment of a vial that includes aremovable and/or replaceable insert for dispensing test strips;

FIG. 10 illustrates additional aspects of the insert illustrated in FIG.9 including a friction fit with a container;

FIG. 11 illustrates a perspective view of an insert that includesgripping portions to facilitate removal of the insert from a container;and

FIG. 12 illustrates a side view of an insert with an inset dispensingmember.

DETAILED DESCRIPTION

Embodiments of the invention relate to systems and methods fordispensing test strips, including test strips used in testing analytes.More specifically, embodiments of the invention relate to a cap thatdispenses test strips in a controlled manner, for example, dispensingthe test strips one test strip at a time. An illustrative vial mayinclude a container and a dispensing member that is configured tofacilitate dispensing of test strips. This illustrative vial includes acontainer that is configured to store a number of test strips, which maybe loosely stored inside the container. The dispensing member, by way ofexample and not limitation, can be integrated with the container orvial, included in a cap for the container, as included in a replaceableinsert and the like.

In addition, the container, dispensing member, cap, or insert can be ofany shape and size, transparent, opaque, translucent, or colored. Inadditional embodiments, the container can also be adapted to be attachedto a meter or can be integrated with a meter.

In one configuration, the cap includes a slot that is shaped and sizedto cooperate with a guiding member to dispense test strips from withinthe container. As discussed in more detail below, the configuration ofthe slot can depend on at least the characteristics of the cap. As aresult, the configuration of the cap can vary. For example, the cap canbe configured to dispense test strips one at a time, or in a manner thatallows a single test strip to be handled even though more than one teststrip may pass through the slot or partially pass through the slot.

The cap dispenses test strips using, by way of example only, a guidingmember and a slot. The cap dispenses test strips in a controlled manner.When the cap is associated with the container, a portion of the cap canbe disposed inside of the container when the vial is assembled. Thisportion of the cap may include a guiding member that, when the cap isconnected to the container, guides the test strips to the slot. In oneembodiment, the cap and the container are a unitary integratedstructure, which may be form molded.

When a user needs a strip, the user can open the vial's cover to exposethe slot. In one example, the user can turn the vial over and gentlyshake the vial. During this process, the guiding member cooperates withthe slot to dispense at least one test strip. This allows the user toeasily handle a particular test strip. When the vial is turned overagain, the cover can be replaced, thereby storing the remaining teststrips within the vial's container. Alternatively, the cap and theguiding member can cooperate in a twisting manner to open or close thevial and/or the slot. Thus, the body of the cap and the guiding membermay be rotationally coupled or coupled such that the body of the cap canmove relative to the guiding member. In a first position, the cap andguide member may block the slot. Rotating or moving the cap and/or theguiding member to a second position opens the slot to permit test stripsto be dispensed.

In another configuration, the cap can be configured as an insert thatcan be repeatedly used with different containers. This insert can beremoved from one container and inserted into another container. Theinsert in this configuration can include a dispensing member (e.g., aslot, a diaphragm, a guiding member or any combination thereof) that isformed to control how test strips are dispensed and may also be formedto fit at least partially within the container. Further, the insert maynot interfere with an existing cover or lid that seals or closes thevial. This allows the insert to be used with multiple containers withoutaffecting the opening and closing of the covers of those vials. Theinsert may also be configured to open and close the vial without acover.

FIG. 1 illustrates one embodiment of vial 100 that can store andcontrollably deliver test strips 150. The vial 100 can include acontainer 102 that receives a cap 104. The container 102 may hold orstore any desired number of test strips 150. The cap 104 is configuredfor dispensing the test strips 150 in a controlled manner, for example,one at a time. The test strips 150 located inside the container 102 canbe loosely packed and are not usually constrained inside the container102. As a result, the cap 104 can dispense the test strips 150 in acontrolled manner without having to control how the test strips arearranged inside of the container 102.

The container 102, as illustrated in FIG. 2A (FIGS. 2A-2C may bereferred to collectively as FIG. 2), in this example, has a generallycylindrical configuration with a base 106 and a wall 108 extending fromthe base 106. The wall 108 terminates at a top edge 110 or rim spacedapart from the base 106. As such, the container 102 has a circularcross-section. It will be understood, however, that the container 102may have any cross-sectional configuration, including, but not limitedto, rectangular, square, polygonal, oval, curved, combinations thereof,or any other configuration that would allow storage of test strips andmay cooperate with a cap that controls the dispensing of the test stripsas contemplated by the invention described herein. Further, thecontainer 102 is an example of a storage reservoir, storage compartment,or vessel that can hold or store items including test strips. The vial100 may also include a moisture control element so that the test stripsremain at a certain humidity.

As illustrated in FIG. 2A, the top end 110 may be configured todetachably connect with the cap 104. FIG. 2A, for example, illustratesthat the top edge 110 may fit within a corresponding groove 126 formedin the cap 104 so that the cap 104 may frictionally engage with the topedge 110. The cap 104 may then be removed from the container 102 byincluding, but not limited to, prying, twisting, popping, levering,screwing, turning, rotating or otherwise overcoming the engagementbetween the cap 104 and the container 102. The cap 104 can be removedand replaced on the container 102 repeatedly or used with othercontainers. In other configurations, the cap 104 and the container 102can be frictionally or mechanically connected together throughcomplementary structures. In another configuration, a portion of the cap104 and the container 102 can have complementary threaded portions thatengage through rotational motion to releasably connect the cap 104 andthe container 102. In still another configuration, the cap 104 and/orthe container 102 can be releasably connected through detents andcooperative receiving apertures or structures.

In an alternative embodiment, the cap 104 may be permanently affixed tothe container 102 or may be formed as a unitary structure. The container102 and the cap 104 may be blow molded, for example, leaving the baseopen. After filling the container 102 with test strips through the openbase, the open base of the container 102 can then be closed with a basecap 106 b. The base cap 106 b can be permanently or semi-permanentlyconnected to the walls 108 of the container 102. The base cap 106 b canbe attached, by way of example only and not limitation, thermal bonding,laser bonding, adhesives, or chemical bonding and the like. The teststrips can then be dispensed through the slot 118.

With continued reference to FIG. 2A, the cap 104 has a stepped uppersurface 112 having a raised peripheral portion 114 and an indentation orrecessed portion 116. A slot 118 extends from the stepped upper surface112 through the body of the cap 104 to the lower surface 120. This lowersurface 120 includes a guiding member 122 that directs the strips 150 ina controlled manner to the slot 118, as will be discussed in more detailhereinafter. Disposed about and spaced apart from a portion of theguiding member 122 is a lip 124. Disposed between the guiding member 122and the lip 124 is the groove 126 configured to receive the top edge 110of the container 102 and selectively retain the cap 104 to the container102. As illustrated, the guiding member 122 partially forms the groove126, however, in other configurations, this need not be the case and thegroove 126 may be spaced apart from the guiding member 122.

As mentioned above, the body of the cap 104 may include the slot 118disposed in the recessed portion 116 of the cap 104. The slot 118 may beshaped to dispense the test strips 150 in a controlled manner. The slot118 can be shaped to permit the passage of a single test strip at a timeor to permit more than one test strip to be dispensed at a time. The cap104 controls how the test strips 150 are dispensed and a user can obtaina test strip without removing the cap 104 and without having to handleor touch other test strips within the container 102. Further, a user caninvert the vial 100 without having the test strips 150 fall out of thevial 100 in a group.

The cap 104 may also further include a lid or cover 130, illustrated bydotted lines, which is configured to seal or close the cap 104 to keepthe test strips 150 inside the container 102 until needed. The cover 130can be part of or separate from the cap 104. As illustrated, the cover130 includes a body portion 132 having tether member 134 extending fromthe body portion 132 to the main body of the cap 104 which connects thecover 130 to the remainder of the cap 104. Extending from the bodyportion 132 is a protrusion 136 that cooperates with the recess 116 toclose and/or seal the cap 104. The protrusion 136 may friction fit withthe recess 116 so that the slot 118 is kept closed until expresslyopened. A tab or extension 138 on the cover 130 can facilitate removingthe cover 130 in order to access the slot 118 and dispense one of thetest strips 150. Alternatively, the cover 130 may fit over the cap 104,as illustrated by cover 230 in dotted line in FIG. 2B. The cover 130 canbe twisted, popped, turned, rotated, pried, leveraged, or otherwiseremoved from the container or the guide member or other lid/cover. Thecontainer described herein can refer to the vial, housing, an integrateddevice, storage compartment, and the like.

With continued reference to FIG. 2A, the illustrative cap 104 includes aguiding member 122. The guiding member 122, when the cap 104 is securedto the container 102, may be disposed inside the container 102. Theguiding member 122 guides one or more of the test strips 150 to the slot118, where the test strips are dispensed through the slot 118 in acontrolled manner. The guiding member 122 can control the number of teststrips that approach the slot 118 when being dispensed.

As illustrated, the guiding member 122 can have a guiding surface 128 todirect the test strips to the slot 118. In this embodiment, the guidingsurface 128 of the guiding member 122 slopes from the base 140 of thecap 104 to the slot 118. In other words, the guiding surface 128 slopesfrom an interior surface of the container 102 to the edges or lowerportion of the slot 118 at a junction 146. The guiding surface 128 canbe smooth to allow the test strips to slide easily towards the slot 118.In one example, the guiding surface 128 forms a funnel-like structure144 having a cross sectional area that decreases towards the slot 118and so guides the test strips 150 to the slot 118 in a controlledmanner. The guiding funnel 144 formed by the guiding member 122terminates at edges 142 or sides of the slot 118. Stated another way,the guide surface or the funnel-like structure may have a frustoconicalconfiguration, which terminates at the edges or sides of the slot 118,with the sides of the funnel-like structure being convex (FIG. 2B),planar (FIG. 2C), combinations thereof, or other configurations to aidguide the test strips to the slot. In this manner, the guiding surface128 may gradually constrict or reduce the area that the test strips 150may occupy thereby reducing the number of test strips that can bedispensed through the slot 118 of the cap 104. This limits the number oftest strips 150 that are able to reach the slot 118. In one example, theguiding surface 128 of the guiding member reduces the area such thatonly a single test strip may pass through the slot 118 at a time. In analternative embodiment, the slot 118 is sized such that a few, such asbetween 1 and 3, test strips can pass through the slot 118 at the sametime. In an alternative embodiment, more than one test strip may passthrough the slot 118 at a time.

FIG. 3 illustrates a top view of one embodiment of the cap 104. The cap104 can be formed as an integral member and may be molded, for examplefrom any suitable material including a polymer or plastic. The plasticused in the cap 104 may be different from the material use to form thecontainer 102. Other materials used in either the cap 104 and/or thecontainer 102 can include, but are not limited to, polymers and otherplastics, polyethylene terephthalate, polyethylene, polyvinyl chloride,polypropylene, polystyrene, metals, alloys, and the like or anycombination thereof. In some instances, the material of the container102 and/or the cap 104 may be coated to provide strength and durabilityto the vial or to provide other characteristics to the surface, such assmoothness or slickness. Surfaces of the cap and/or the container may becoated, by way of example only and not limitation, with Teflon or othermaterial that may provide a smooth or slick surface that may assist indispensing test strips. For example, coating the guiding surface 128 canprovide a surface that allows the test strips to be guided more easilyto the slot 118 and slide on the surface 128.

FIG. 3 illustrates an example of the slot 118 formed in a center portion130 of the cap 104. The slot 118 could alternatively be placed at otherlocations on the cap 104, including off-center. In this example, theslot 118 has an oval shape that is sized to accommodate at least onetest strip. Dimension D₁ of the slot 118 can be less than the sum ofdimension S₁ of two test strips and dimension D₂ of the slot 118 is lessthat the sum of dimension S₂ of two test strips. This allows a singletest strip to pass through at a time. In one example, the dimensions D₁and D₂ are larger than the corresponding dimension S₁ and S₂ of a teststrip such that a test strip can pass through the slot freely, while twotest strips cannot pass through at the same time. Optionally, and asillustrated in FIGS. 2B and 2C, the edges 142 of the slot 118 on thestepped upper surface 112, illustrated in FIG. 2B, and/or the edges 146of the slot 118 on the lower surface 120 may be rounded to assist indispensing a test strip. As such, the dimension D₁ of the slot 118 canbe about 0.1 mm to about 5 mm. The dimension D₂ of the slot 118 canrange between about 2.0 mm to about 15.0 mm. These dimensions D₁ and D₂of the slot 118 are provided by way of example and not limitation. Thedimensions D₁ and D₂ can be smaller or larger. In one example, the slot118 is sized and configured for a desired test strip. In one embodiment,the slot 118 may have a thickness that is less than a thickness of twotest strips and a width that is less than a width of two test strips.

The slot 118 is an example of a dispensing member and can be placed inany portion of the cap 104. The slot 118 may be placed, for example, ona side of the cap 104. In this case, the vial or wall of the containercan form at least a portion of the slot.

FIG. 4 illustrates another embodiment of the cap, identified byreference numeral 104 b. In this embodiment, the guiding surface 128 bslopes to the lower surface 122 b of the cap 104 b. A transition portion146 b is present on the lower surface 122 b between the edge 142 b tothe slot 118 and the guiding surface 128 b in this example. The width ofthe transition portion 146 b can vary in different embodiments. Further,the junction 148 b between the guiding surface 128 b and the transitionportion 146 b can form a corner between the guiding surface 128 b andthe transition portion 146 b or a smooth transition from the guidingsurface 128 b to the transition portion 146 b. In addition, the slope ofthe guiding surface 128 b can vary. In addition, at least some of thecomponents of the vial (e.g., the container, the cap, the slot, theguiding member, or any portion thereof) can be transparent, translucent,colored, and the like. This may enable a user to view the test stripsinside the vial and help the user dispense test strips therefrom.

FIG. 5 illustrates an embodiment of how a test strip may be dispensedfrom the vial 100 of FIG. 1. In this example, the vial 100 is invertedand may be shaken by a user. The funnel-like structure 144 or theguiding member 122 guides the test strips 150 towards the slot 118. Aspreviously indicated, the funnel-like shape 144 defined by the guidingmember 122 effectively reduces the area available for the test strips150, which allows some of the test strips 150 to move towards the slot118. Because the slot 118 can be sized to permit a single test strip toexit the cap 104 of the vial 100, a single test strip may be dispensed.In this example, the test strip 150 extends out of the slot 118 and maybe easily handled by a user. A user, for example, can shake a singletest strip into his or her hand. Advantageously, the user is notrequired to remove the cap 104 and attempt to extract a single stripfrom among many strips. Further, the test strip 150 that is dispensedcan be grasped without interference from other test strips stored in thevial 100.

The slot 118 illustrated in FIG. 5 can be relatively firm and fixed.More specifically, the slot 118 does not change shape or deform whendispensing test strips. In one embodiment, the cap 104 may therefore berigid when connected with the container 102, although it may not beinflexible. In this example, the cap 104 can dispense the test strips ina controlled manner by configuring the shape and size of the slot 118and/or the slope and position of the guiding member 122 relative to theslot 118.

FIG. 6 illustrates another embodiment of a cap 204 for a vial 200. Inthis example, the cap 204 has a soft diaphragm 260 formed in a recessedportion 216 of the cap 204. The diaphragm 260 has a slit 218 that isformed by cross cuts 219 a and 219 b. The cross cuts 219 a and 219 b canbe of different lengths. In another example, the slit 218 is formed froma single cross cut. Alternatively, the slit 218 may be formed from two,three, four, or more cross cuts.

The diaphragm 260 may a flexible material that permits one or more teststrip to be dispensed. While the cap 104 includes a slit 118 that isrelatively fixed, the slit 218 of the cap 204 has flexibility that canbe controlled, in one example, by the length of the cross cuts 219 a and219 b or by the material and its thickness used to form the diaphragm,or by a combination thereof. At the same time, the diaphragm 260 may berigid enough to exert a force that allows one or more test strips to bedispensed while preventing the test strips from falling out of the vial200.

In other words, the cap 204, and in particular the diaphragm 260, tendsto grip the test strips as they exit the vial such that a user may graspone of the test strips from those gripped or held in place in adispensing position by the diaphragm 260 of the cap 204. The diaphragm260 may returns to its original shape and form after being deformed. Thediaphragm 260 may be formed of a suitable material, such as natural orsynthetic rubber, silicon, or polymer, and the like or any combinationthereof.

Turning to FIG. 7, illustrated is an exploded version of the cap 204. Asshown, the cap 204 includes a first cap portion 262, a second capportion 264, and the diaphragm 260. Generally, the first cap portion 262receives the diaphragm 260 and the second cap portion 264, with thesecond cap portion 264 aiding to retain the diaphragm 260 within thefirst cap portion. The first cap portion 262 has a generally annularconfiguration have a generally planar upper portion 270. An aperture 272extending from the upper portion 270 to a lower stepped portion 274having a peripheral portion 276 and a recessed portion 278. The recessedportion 278 is configured to receive the diaphragm 260 within.

The recessed portion 278 is also configured to receive at least aportion of the second cap portion 264. The second cap portion 264 alsoincludes a generally planar upper portion 280. An aperture 282 extendingfrom the upper portion 280 to a lower guiding member 284, which can besimilar to the other guiding members described herein including aguiding surface 284. The aperture 282 can have a similar configurationto the slots of described previously, including, but not limited to,slot 118 of FIGS. 2A-4.

In another configuration, the aperture 282 defined by the second capportion 264 may have a generally annular shape, as indicated by themember 292. The member 292 thus defines an annular shaped openingbeneath the diaphragm 260. The diameter of the opening 282 defined bythe annular guiding member 292 may be greater than the length of thecross cuts in the slit 218. As a result, the guiding member 292 mayallow more than one test strip to reach the slit 218. The slit 218 maycontrol how the test strips are dispensed. Thus, the guiding member 292may provide support for the diaphragm 260 to hold the diaphragm relativeto the test strips.

In one example, several test strip may partially pass through the slit218 and are then held in a dispensing position. A user may select aspecific test strip from those that extend through the diaphragm 260 andthe remaining test strips are returned to the container. In thisexample, the aperture 282 may provide access to the diaphragm 260,through which at least one test strip may be dispensed at a time. Inthis example, the second cap portion 264 provides a base portion onwhich the diaphragm 260 is placed. In this example, the diaphragm can beretained by adhesive bonding, thermal bonding, and the like. The baseportion receives the diaphragm 260 and forms an aperture 282 that allowstest strips to reach the slit 218 of the diaphragm. The diaphragm 260can also be over molded on the second cap portion 264, in which case thefirst cap portion 262 may not be required to form the cap 204.

About a periphery of the second cap portion 264 is a stepped sidewall286 that includes an upper sidewall portion 288 and a lower sidewallportion 290 separated by a transition or step 292. Upper sidewallportion 288 is configured to couple with the stepped lower portion 278of first cap portion 262, while lower sidewall portion 290 may beconfigured to frictionally engage with an interior of the container 102to retain the container 102 to the cap 204. The top edge 110 of thecontainer 102 can engage with the transition or step 292 and/or aportion of the first cap portion 262 upon the cap 204 being formed fromthe diaphragm 260, the first cap portion 262, and the second cap portion264. In this configuration, therefore, the outer diameter of uppersidewall portion 288 is greater than that of the lower sidewall portion290. In other configurations, however, this need not be the case andupper sidewall portion 288 can have a smaller or equal diameter to thatof the lower sidewall portion 290.

FIG. 8 illustrates an example of a vial 200 with a cap 204 thatdispenses test strips 150 in a controlled manner. In this example, thevial 200 has been inverted. The vial 200 in FIG. 8 illustrates thestrips 150, which may include one or more test strips 152, extending outof the cap 204. As the test strips 150 begin to pass through the slit218, the diaphragm 260 deforms and exerts an inward force on the teststrips 150. The diaphragm 260 thus holds the test strips 152 in place orin a dispensing position, allowing a user to grasp and withdraw aparticular test strip. In this example, the diaphragm 260 may beassisted by the guiding member 284, which guides or directs the teststrips 150 toward the slit 218 in the diaphragm 260. Alternatively, theguiding member 284 provides structure to support the diaphragm 260 andmay define an aperture to provide access to the slit 218. As a result,embodiments of the guiding member can direct test strips to a slit orprovide access to the slit while providing structural support to retainthe diaphragm in a particular position. The aperture formed by theguiding member 284 is typically located adjacent to the inner surface ofthe container 102 and provide a support ledge to the diaphragm 260. FIG.8 illustrates that the diaphragm 206 controls how the test strips aredispensed.

In one example, the guiding member 284 may control the number of teststrips 150 that are allowed to pass through the slit 218 of the cap 204.Alternatively, the opening defined by the structure 284 may allowmultiple test strips access to the slit 218. The elasticity of the slit218 holds the test strips that at least partially pass through the slit218 in a dispensing position and one of the exposed test strips may beselected.

After a test strip is selected by the user, the vial 200 may beinverted, causing the strips to fall back into the container 102.Alternatively, gently shaking the vial 200 may return the test stripsinto the container 102 from the dispensing position. As with the cap 104(FIG. 2A), a cover 130 may then be replaced to close or seal the vial200.

As mentioned above, the aperture 282 of the second cap portion 264 canhave a similar configuration to that of slot 118 of FIGS. 2A-4.Alternatively, the aperture 282 may be larger and define an annularshaped opening, although the aperture 282 can be configured to providestructure that supports the diaphragm and partially guides strips towardthe slot. When combined with the slit 218 formed in diaphragm 260multiple test strips may be able pass through the aperture 282 to theslit 218. In this alternate example, the guiding member 284, similar tothe other guiding members described herein, may guide some of the teststrips 150 towards the slit 218 or may provide structure to support thediaphragm 260 on the cap 204. The diaphragm 260 allows some of thosetest strips to pass through the slit 218. Test strips are then held bythe diaphragm 260 and a user can easily grasp a single test strip.

In another embodiment, the aperture 282 may be sized to permit a singletest strip to pass thorough it at a time. The diaphragm 260 then gripsthat single test strip such that it can be handled by a user. Thus, theslit 218 in the diaphragm 260 and/or the guiding member 284 maycooperate to dispense a single test strip. In this embodiment, thediaphragm may prevent the test strip from simply falling out into auser's hand, but allows the user to grasp the test strip instead. In oneembodiment, the diaphragm 260 controls how the test strips are dispensedfrom the container while the guiding member can assist in dispensing thetest strips or be enlarged to provide a ledge or support such that thediaphragm 260 is retained in the cap 204.

FIGS. 9A and 9B illustrate another embodiment of a vial 300 in a closedposition and in an expanded view. In this example, the vial 300 includesa container 302 similar to the container 102 illustrated at least inFIG. 1. The container 302 includes an additional layer 304 disposed onan interior surface of the container 302. The layer 304 may be formed ofa desiccant plastic and is configured to absorb at least water toprotect any test strips held, stored, or supported by the container 302or to control the humidity of the test strips. The layer 304 may belocated on any portion of the interior surface of the container 302. Inthis example, the layer 304 is disposed on the base and on the walls ofthe container 302. The layer 304 terminates inside the container 302 toform a shoulder 316 near a top end of the container 302. The shoulder316 may alternatively be formed of polymer or may be thicker than thelayer 304.

FIG. 9A further illustrates an example of an insert 350 that can be usedwith one or more containers and that is inserted into a container. Theinsert 350 in this example is configured to be removable or changeablewith other containers. FIG. 9B, for example, illustrates an insert 350that has been removed from the container 302 or that can be insertedinto the container 302.

In this example of FIGS. 9A and 9B, the insert 350 cooperates with thecontainer 302 to control how test strips are dispensed. The insert 350may be configured to be disposed inside the container 302 such that theexisting cover 312 that may be attached to the container 302 can be usedto close the vial 300 and prevent test strips from exiting the containerthrough the slot 356 inadvertently. Test strips can be stored in thecontainer 302 with or without the presence of the insert 350. However,the insert 350 can control how the test strips are dispensed from thecontainer 302.

The insert 350 can be configured to cooperate with the container 302 inmultiple configurations. In this example, the top surface 318 of theinsert 350 is flush with the rim or top end 310 of the container 302.Alternatively, the insert 350 may be inset with respect to the rim ortop end 310. In either example, the cover 312 functions the same toclose the container 302 whether or not the insert 350 is associated withthe container 312. In the example of FIG. 9A, the insert 350 is insertedinto the container 302 such that the ridge 308 of the cover 312 engageswith corresponding ridge 310 to close or seal the slot 356 in the insert350 of the vial 300. Using the tab 358, the cover 312 can be opened toexpose the slot 356 of the insert 350 and dispense a test strip. Theguiding member 352 and guiding surface 354 can be similar to otherembodiments disclosed herein.

In FIGS. 9A and 9B, the layer 304 is configured to present a shoulder316. The shoulder 316 positions the insert 350 within the container 302or controls the depth to which the insert 350 may be inserted in thecontainer 302. In this example, the insert 350 is positioned such thatthe cover 312 can seal or close the container 302.

In FIG. 9A, the insert 350 is separate from the cover 312 can be usedwith more than one container. In other words, the insert 350 isremovable such that it can be removed from the container 302 asillustrated in FIG. 9B and placed in another container. At the sametime, the insert 350 can be properly positioned within each separatecontainer, for example by using the shoulder 316 to control how far theinsert 350 is inserted inside the container 302. Further, the shoulder316 may be positioned to prevent the insert 350 from damaging the teststrips during insertion of the insert 350 into a container.

FIG. 9A also illustrates a grip portion 372 that is formed, in thisexample, in the guiding member 352. The grip portion 372 can be graspedby a user when removing the insert 350 from the container 302.Alternatively the tool 370, which has an extraction member 376 on oneend, may be used to remove the insert 350. The extraction member 376 canbe inserted into the container 302 through the slot 356. The extractionmember 376 has dimensions that allow it to be inserted and removed fromthe slot 256 when in a particular orientation. When the tool is turned,the extraction member 376 cooperates with the bottom surface of theinsert 350 to pull the insert 350 out of the container 302. The insert350 can then be pushed or inserted into another container. In thisexample, the grip portion 372 may include a ledge 374 that allows a userto use the tool 370 as a lever to pry the insert 350 out of thecontainer. FIG. 11, by way of example, is a perspective view of the gripportion 372 that can be used to extract the insert 350 from thecontainer 302.

FIG. 10 illustrates additional aspects of the insert 350 and/orcontainer 302. The insert 350 also includes a diaphragm 362 disposed onthe upper surface 318 of the guiding member 352. In this example, thecontainer 302 includes a shoulder 316 b that is formed as a ledge on aninterior surface of the container 302. The shoulder 316 b may provide astop to prevent the insert 350 from being inserted too far inside thecontainer 302 or to properly position the insert 350 inside thecontainer 302 or to prevent inadvertent damage to any test strips storedtherein. The shoulder 316 b may also control the distance between theaperture 320 and a cover (such as the cover 312) or between the topsurface 318 of the insert 350 and a top end 310 of the container 302.When inserted in a container, the insert 350 may be flush with the topend of the container 302 such that the cover can be closed asillustrated in FIG. 9. Alternatively, the top surface 318 insert 350 maybe below the level of the top end 310 of the container 302.

In this example the insert 350 further includes a retention member 360disposed on or around at least a portion of a periphery surface of theguiding member 352. The retention member 360 may be integrated with thediaphragm 362 or be separate from the diaphragm 362. The retentionmember 360 is typically formed of rubber, silicone, or other suitablematerial that can grip the inner surface of the container 302 andprevent the insert 350 from becoming inadvertently dislodged from itsdispensing position. Gripping the inner surface of the container 302 orcreating a friction fit between the insert 350 and the container 302ensures that the insert 350 does not fall out of the container 302, butis held in position until specifically removed from the container 302.

The retention member 360 may have a smooth surface, a textured surface,a ridged surface, or any other configuration that allows the retentionmember 360 to grip the inner surface of the container 302 or to be heldin place relative to the container 302. The retention member 360 mayalso be serrated, have different thicknesses at different locations, andthe like or any combination thereof. The retention member 360 may bedisposed on the periphery surface of the insert 350 that is adjacent theinterior surface of the container 302 when associated with the container302. Alternatively, the retention member 360 may be disposed on aportion of the periphery surface. Thus, the retention member 360 may becontinuous on the periphery surface or in distinct non-continuoussegments. In another example, the periphery of the insert may include arecessed portion configured to receive the retention member 360.

In addition, the retention member 360 may be formed of a compressiblematerial that enables the insert 350 to account for containers that havedifferent dimensions. As the dimensions (e.g., diameter, circumference,perimeter) of the container may change from one container to the next,the retention member 360 may allow the insert 350 to be used withmultiple containers.

FIG. 12 illustrates additional aspects of the insert 350 b, whichincludes grip portions 372. In this example, the guiding member 352 bincludes a ledge 378 that provides support for the diaphragm 362. Thediaphragm 362 may be connected to the ledge 278 via adhesive bonding,thermal bonding, and the like. The aperture 380 formed by the guidingmember 352 b provides access to the cross cuts or slot in the diaphragm362, which dispenses test strips similarly to other embodiments of thediaphragm described previously. The grip portions 372 allow a user toremove the insert 350 b from a container using a tool such as the tool370 or with his or her fingers. In this embodiment the top surface ofthe diaphragm 362 may be substantially flush with the surface 318. Theshape of the aperture 380 defined by the guiding member 352 b, by way ofexample only and not limitation, can be annular, partially conical, andthe like or any other shape identified herein.

As described herein, the dispensing member can be formed as a slot, aslot and a guiding member, a diaphragm with a slit, and the like andcombinations thereof. Additional embodiments of the dispensing memberinclude bristles arranged over the aperture formed by the guidingmember. The bristles can be arranged in adjacent rows connected toopposite sides of the insert or cap. The bristles extend over theaperture of the guiding member and may overlap or touch in the middle.The bristles have flexibility such that the junction between the rows ofbristles allows one or more test strips to pass through the junction.The bristles typically have sufficient stiffness to exert a force on thetest strips that pass partially through the junction to hold the teststrips in the dispensing position such that a user may grasp aparticular test strip the remaining test strips are then returned to thecontainer. Alternatively, the bristles can be arranged in an annularconfiguration such that the ends of the bristles meet in a centerportion of the aperture.

The method for dispensing test strips can be similar for variousembodiments of the vial's caps. The vial may be inverted and thenshaken. A user can then handle a test strip that is dispensed throughthe slot of the cap. In some embodiments, the cap can be removed and thevial can be refilled with additional test strips at any time.Alternatively, the vial can be disposable when empty.

Inverting the vial moves a plurality of test strips toward a slot formedin a portion of a cap of the vial. The guiding member then guides ordirects the plurality of test strips towards the slot and may reduce thenumber of test strips that approach the slot. Then, the slot dispensesat least one test strip.

Generally, the vial, and the cap, can be fabricated from variousmaterials that are compatible with dispensing test strips for testinganalytes. For instance, medical grade polymers and plastic areapplicable. In addition, the materials can include polymers such as, byway of example only, polyethylene terephthalate, polyethylene, polyvinylchloride, polypropylene, polystyrene, metals, alloys, and the like orany combination thereof. The diaphragm can be fabricated from variousmaterials including, but not limited to, silicone, natural and syntheticrubbers, and the like or any combination thereof. Reference has beenmade to mechanical or frictional engagement of cap to container and ofcap portions to one another and/or to the diaphragm. It will beunderstood by those skilled in the art that sonic welding, thermalwelding, adhesives, can be used to releasably, permanently, orsemi-permanently join or attach one or more of the elements or portionsof the vials, caps, diaphragms, and/or inserts together. In addition,the ability of a cover or cap to seal a vial can use various forms tojoin or attach elements of portions of the vials.

Embodiments of the invention may be embodied in other specific formswithout departing from its spirit or essential characteristics. Thedescribed embodiments are to be considered in all respects only asillustrative and not restrictive. The scope of the invention is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

Embodiments of the invention may be embodied in other specific formswithout departing from its spirit or essential characteristics. Thedescribed embodiments are to be considered in all respects only asillustrative and not restrictive. The scope of the invention is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

1. An insert for dispensing test strips from a container, the insertcomprising: a body configured to be removable from an associatedcontainer; a dispensing member formed in a center portion of the body;and a guiding member extending from the body and defining an aperturebetween the dispensing member and the test strips, wherein test stripsare dispensed through the dispensing member at least one at a time. 2.The insert recited in claim 1, further comprising a retention memberformed on at least a portion of a periphery surface of the body, whereinthe retention member holds the body in a particular position wheninserted into the container.
 3. The insert recited in claim 1, whereinthe dispensing member further comprises a diaphragm supported by theguiding member, the diaphragm having a slit that includes one or morecross cuts.
 4. The insert recited in claim 3, wherein the diaphragm andthe retention member are integrated.
 5. The insert recited in claim 3,wherein the retention member has a textured surface to grip an innersurface of the container and wherein the guiding member comprises aguiding surface that directs some of the test strips toward the slit. 6.The insert recited in claim 1, wherein the dispensing member exerts aninward force on the test strips to hold test strips that partially passthrough the dispensing member in a dispensing position.
 7. The insertrecited in claim 6, wherein the dispensing member flexes to hold thetest strips in the dispensing position when dispensing the at least onetest strip.
 8. The insert recited in claim 1, wherein the body comprisesat least one grip portion configured for extracting the insert from theassociated container.
 9. The insert recited in claim 3, wherein theguiding member comprising a recess configured to receive the diaphragm,wherein the diaphragm attaches to a ledge formed in the recess such thatthe a surface of the diaphragm is substantially flush with top surfaceof the body.
 10. The insert recited in claim 1, wherein the dispensingmember comprises slot formed in a center portion of the body and whereinthe guiding member comprises a guiding surface that directs test stripstoward the slot.
 11. The insert recited in claim 1, wherein the slot isdimensioned and configured to dispense a single test strip at a time.12. The cap recited in claim 11, wherein the slot has a width less thana width of two test strips and a thickness less than a thickness of twotest strips.
 13. A cap for dispensing test strips from a vial, the capcomprising: a body associated with a container, the body comprising: adispensing member associated with the body portion, the dispensingmember passes a portion of the test strips partially through thedispensing member to a dispensing position, wherein a particular teststrip is selected; and a guiding member that supports the dispensingmember in the container, wherein particular test strip is dispensedthrough the dispensing member.
 14. The cap recited in claim 13, whereinthe dispensing member comprises a diaphragm having a slit formed from atleast one cross cut.
 15. The cap recited in claim 14, wherein theguiding member forms an aperture between the dispensing member and thetest strips, wherein the aperture is wider than the at least one crosscut.
 16. The cap recited in claim 14, wherein the at least one cross cutexerts an inward force on a test strip that is being dispensed throughthe dispensing member.
 17. The cap recited in claim 13, furthercomprising a cover connected with the body portion, wherein the covercomprises a member that operatively cooperates with the cap to close thedispensing member.
 18. The cap recited in claim 13, wherein the guidingmember comprises a guiding surface that slopes from an inner surface ofthe container to the dispensing member to gradually reduce a crosssectional area of a region defined by the guiding member.
 19. The caprecited in claim 13, wherein the body is integrated with the container.20. A vial for dispensing test strips in a controlled manner, the vialcomprising: a container for holding test strips, the container having aninner surface; and a removable insert configured to dispense the teststrips from the container in a controlled manner, the insert comprising:a dispensing member configured in a center portion of the insert, thedispensing member configured to hold some of the test strips in adispensing position such that a particular test strip is dispensedthrough the dispensing member.
 21. The vial as recited in claim 20,wherein the dispensing member comprises a slot that is dimensioned andconfigured to a single desired test strip and the removable insertfurther comprises a guiding member that defines a funnel-shaped regioninside the container, the guiding member having a guiding surface thatguides at least one test strip to the slot.
 22. The vial as recited inclaim 21, wherein the guiding surface slopes from an inner surface ofthe container to a bottom surface of the center portion and wherein theguiding surface is coated with a material to increase a slickness of theguiding surface.
 23. The vial as recited in claim 20, wherein thedispensing member comprises a diaphragm, the diaphragm having a slitformed from at least one cross cut arranged over the slot, wherein theexerts an inward force on the test strips that pass partially throughthe slit when the particular test strip is dispensed.
 24. The vial asrecited in claim 20, wherein the dispensing member comprises a pluralityof bristles arranged over a guiding member, the bristles arranged toform a junction that allows some of the test strips to at leastpartially pass through the bristles to hold the test strips in thedispensing position.
 25. A method for dispensing test strips from avial, the method comprising: inverting the vial to move at least onetest strip toward a dispensing member formed in a portion of a cap ofthe vial; guiding the at least one test strip with a guiding member, theguiding member reducing a number of strips that approach the dispensingmember; and dispensing at least one of the test strips through the slot.26. The method of claim 25, further comprising loading the vial with theplurality of test strips and associating the cap with a container toform the vial.
 27. The method of claim 25, further comprising theguiding member holding the at least one test strips in a dispensingposition while dispensing at least one of the test strips.